Bristol Laboratories Ltd RX
FDA Approved Drugs

Bristol Laboratories Ltd RX

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

RX
  • Total Records 19
  • Latest Approval Date Apr 17, 2025
  • Data Source FDA
  • First Approval Date Feb 08, 2013
All
83
View
Unclassified
3
View
Discontinued
61
View
RX
19
View
Company Overview

Company

Bristol Laboratories Ltd RX

Country

United Kingdom

Website

Visit Website

Email

info@bristol-labs.co.uk

Social Profiles

Company Snapshot

Bristol Laboratories Ltd RX

Bristol House, Unit 3, Canalside, Northbridge Road Berkhamsted, Hertfordshire

United Kingdom

bristol-labs.co.uk/ info@bristol-labs.co.uk View on Map
FDA Approved Drug Records ( 19 records )
2023
15 Nov
RX Application: 218213

Drug Name

AUGTYRO

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2023-11-15

218213 / 1

Active Ingredient

REPOTRECTINIB

Application Number

218213

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2023-11-15

Regulatory Status

RX

2024
11 Jun
RX Application: 218213

Drug Name

AUGTYRO

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2024-06-11

218213 / 2

Active Ingredient

REPOTRECTINIB

Application Number

218213

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2024-06-11

Regulatory Status

RX

2022
28 Apr
RX Application: 214998

Drug Name

CAMZYOS

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2022-04-28

214998 / 1

Active Ingredient

MAVACAMTEN

Application Number

214998

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2022-04-28

Regulatory Status

RX

2022
28 Apr
RX Application: 214998

Drug Name

CAMZYOS

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2022-04-28

214998 / 2

Active Ingredient

MAVACAMTEN

Application Number

214998

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2022-04-28

Regulatory Status

RX

2022
28 Apr
RX Application: 214998

Drug Name

CAMZYOS

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2022-04-28

214998 / 3

Active Ingredient

MAVACAMTEN

Application Number

214998

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2022-04-28

Regulatory Status

RX

2022
28 Apr
RX Application: 214998

Drug Name

CAMZYOS

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2022-04-28

214998 / 4

Active Ingredient

MAVACAMTEN

Application Number

214998

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2022-04-28

Regulatory Status

RX

2025
17 Apr
RX Application: 220073

Drug Name

ELIQUIS SPRINKLE

Product Number

1

Dosage Form

-

Strength

0.15MG

Approval Date

2025-04-17

220073 / 1

Active Ingredient

APIXABAN

Application Number

220073

Product Number

1

Dosage Form

-

Strength

0.15MG

Approval Date

2025-04-17

Regulatory Status

RX

2015
29 Jan
RX Application: 206353

Drug Name

EVOTAZ

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE;150MG

Approval Date

2015-01-29

206353 / 1

Active Ingredient

ATAZANAVIR SULFATE; COBICISTAT

Application Number

206353

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE;150MG

Approval Date

2015-01-29

Regulatory Status

RX

2022
12 Dec
RX Application: 216340

Drug Name

KRAZATI

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2022-12-12

216340 / 1

Active Ingredient

ADAGRASIB

Application Number

216340

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2022-12-12

Regulatory Status

RX

2020
01 Sep
RX Application: 214120

Drug Name

ONUREG

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2020-09-01

214120 / 1

Active Ingredient

AZACITIDINE

Application Number

214120

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2020-09-01

Regulatory Status

RX

2020
01 Sep
RX Application: 214120

Drug Name

ONUREG

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2020-09-01

214120 / 2

Active Ingredient

AZACITIDINE

Application Number

214120

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2020-09-01

Regulatory Status

RX

2013
08 Feb
RX Application: 204026

Drug Name

POMALYST

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2013-02-08

204026 / 1

Active Ingredient

POMALIDOMIDE

Application Number

204026

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2013-02-08

Regulatory Status

RX

2013
08 Feb
RX Application: 204026

Drug Name

POMALYST

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2013-02-08

204026 / 2

Active Ingredient

POMALIDOMIDE

Application Number

204026

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2013-02-08

Regulatory Status

RX

2013
08 Feb
RX Application: 204026

Drug Name

POMALYST

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2013-02-08

204026 / 3

Active Ingredient

POMALIDOMIDE

Application Number

204026

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2013-02-08

Regulatory Status

RX

2013
08 Feb
RX Application: 204026

Drug Name

POMALYST

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2013-02-08

204026 / 4

Active Ingredient

POMALIDOMIDE

Application Number

204026

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2013-02-08

Regulatory Status

RX

2022
09 Sep
RX Application: 214958

Drug Name

SOTYKTU

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2022-09-09

214958 / 1

Active Ingredient

DEUCRAVACITINIB

Application Number

214958

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2022-09-09

Regulatory Status

RX

2020
25 Mar
RX Application: 209899

Drug Name

ZEPOSIA

Product Number

1

Dosage Form

-

Strength

EQ 0.23MG BASE

Approval Date

2020-03-25

209899 / 1

Active Ingredient

OZANIMOD HYDROCHLORIDE

Application Number

209899

Product Number

1

Dosage Form

-

Strength

EQ 0.23MG BASE

Approval Date

2020-03-25

Regulatory Status

RX

2020
25 Mar
RX Application: 209899

Drug Name

ZEPOSIA

Product Number

2

Dosage Form

-

Strength

EQ 0.46MG BASE

Approval Date

2020-03-25

209899 / 2

Active Ingredient

OZANIMOD HYDROCHLORIDE

Application Number

209899

Product Number

2

Dosage Form

-

Strength

EQ 0.46MG BASE

Approval Date

2020-03-25

Regulatory Status

RX

2020
25 Mar
RX Application: 209899

Drug Name

ZEPOSIA

Product Number

3

Dosage Form

-

Strength

EQ 0.92MG BASE

Approval Date

2020-03-25

209899 / 3

Active Ingredient

OZANIMOD HYDROCHLORIDE

Application Number

209899

Product Number

3

Dosage Form

-

Strength

EQ 0.92MG BASE

Approval Date

2020-03-25

Regulatory Status

RX

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Drug Status Breakdown
19 total
  • RX
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

AUGTYRO

Application Number

218213

Product Number

1

Active Ingredient

REPOTRECTINIB

Dosage Form

-

Strength

40MG

FDA Approved Drug Data

Approved drug product information

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